The present invention relates to an infusion pump device.
In medical practice, infusion pumps have been used in various ways to pump and forward liquid pharmaceutical substances, wherein the oldest method using a rotary peristaltic pump has been set up in 1881 which pump comprises an elastic pipe fixed in the edges of a “U”, a rotating spool, peripheral rotors in the rounded portion of the “U”, and a tightened rubber used to close the free flow and to pump the enclosed liquid to an exit nozzle (cf. U. S. Pat. No. 249,285 A). The deficiency of this arrangement, that the pipe is pulled in upstream direction and is amassed in the downstream direction which destroys the accuracy of the dose, was historically corrected by U.S. Pat. No. 2,412,397 A in 1943 which teaches the provision of a linear peristaltic pump and has been therefore called “linear peristaltic” and is currently greatly preferred in the majority of the medical infusion pumps using three or more fingers to gradually squeeze a resilient tube against a plate for forwarding the liquid. For such an arrangement, U.S. Pat. No. 5,980,490 A discloses the provision of six finger followers driven by respective cams for squeezing a linear resilient pipe so as to close it gradually and push the liquid without any pulling of the pipe since the followers are moved only vertically and therefore no longitudinal force occurs.
By adding a spool pressure cylinder in the perimeter where the resilient tubing is pressed against it, the accuracy of the rotary peristaltic pump could be improved because it was not necessary anymore to pull the tubing for closing the flow anymore, but the tubing continues to be tightened by the peristaltic motion of passive rollers. Recently, the rotary peristaltic pump is provided with a flexible, but inelastic sheet inserted between the rotors of the spool and the pipe so that the pipe is not pulled due to the rotation, or similarly with inelastic liner-fibers inserted inside the resilient tubing in order to avoid pulling. Furthermore, the rotor has been provided with active (and not passive) rotating rollers (having gears) so that the pipe is not pulled, and more recently the tubing is fixed at the pressure cylinder (cf. U.S. Pat. Nos. 5,342,181 A and 8,062,009 A), or in a vertical arrangement the pipe is horizontally pressed against a semi-circle element (cf. U.S. Pat. No. 7,074,021 A) or against a half hard plastic element and a half elastic horizontal element (U.S. Pat. No. 6,572,349 A). U.S. Pat. No. 7,918,657 A deals with the bouncing back of the tubing after the compression for a better accuracy. A gear bearing is described in U.S. Pat. No. 6,626,792 A.
The provision of a cartridge for a medicine bag is another improvement in the prior art, which cartridge initially has had only an elastic infusion pipe (cf. U.S. Pat. No. 6,202,708 A) or more facilities such as valves (cf. U.S. Pat. No. 6,165,154 A) and/or a pressure sensor (cf. U.S. Pat. No. 6,572,349 A). Also hydraulic arrangements at the cartridge facilitate its placement onto the pump which usually requires a persistent loading procedure of the pipe and security accessories or connections in the prior art (cf. U.S. Pat. No. 6,494,694 A).
Due to the pressure on prices in the market, there is a need for developing new, more effective and cheap medical infusion pumps with better accuracy.
In the prior art, consumable pump sets contain many parts to be welded in series, such as filters, flows clamps, anti-syphon valves, and Y-connections for other tubings, i.e. many parts which are to be placed in series with an intermediary infusion tubing and many junctions of parts which must be handmade since an automatic production is too difficult, resulting in high parts costs and complicated assembly.
It is an object of the present invention to provide a consumable set having a small size appropriate for evermore smaller pumps and having all its relevant functionalities realized on one part which is to be automatically assembled.
The size, weight and portability of a pump depend on its power consumption. When the tubing is to be pressed, a high energy consumption is needed to fold its sidewall from an “O” figure gradually to an “8” figure and then to an “I” figure where the flow stops. The vertical parts of the “O” cross-section of the tubing are essentially not made to be folded, and in the linear or rotary peristaltic pumps of the prior art an unnecessary consumption of energy occurs because of the resilient tubing section form.
It is a further object of the present invention to provide an infusion pump with a small size (pocket size) for personal infusion care, usually to be provided on the body of a chronic patient, for medicines like insulin for diabetes patients, DUODOPA or Apomorphine for Parkinson patients, Flolan for pulmonary hypertension, or Immunoglobulin for immune system problems, with great accuracy and flow linearity, with easy placement of a consumable infusion cartridge by the patients themselves at home, at low costs, also with the possibility of an alternative version to be used in hospitals with a minimal-sized pump on a spike itself, with higher infusion rates for general infusions, and with the use of a user interface display which, if needed, can be linked wirelessly or wired with the pump.
The provision of multi-layer flexible plastic foils for the manufacturing of medicine bags with layers which protect the transfer of gas or vapor from and to the medicine allows the compounding of bags ready to use in the pump either as a laboratory compounding for shorter stability or as a pharmaceutical packaging for longer stability of more or less than one year.
It is a further object of the present invention to provide a consumable infusion cartridge for a pump which allows the provision of a compounding long before its use, with no risk by the user himself, while the design and construction of the device shall contain all the necessary parts mentioned above in one and the same fitting so as to minimize the manual manufacturing and bonding and to allow an automatic assembly resulting in a reduction of the costs.